Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10-milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.
This rule is effective June 26, 2009.Start Further Info Start Printed Page 30464
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Dechra, Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom, filed a supplement to NADA 141-291 that provides for use of VETORYL (trilostane) Capsules in dogs for treatment of pituitary-dependent hyperadrenocorticism and for treatment of hyperadrenocorticism due to adrenocortical tumors. The supplement provides for the use of a 10-milligram capsule size. The supplemental NADA is approved as of June 5, 2009, and the regulations are amended in 21 CFR 520.2598 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
List of Subjects in 21 CFR Part 520End List of Subjects Start Amendment Part
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In paragraph (a) of § 520.2598 remove “30 or 60 milligrams” and in its place add “10, 30, or 60 milligrams”.End Amendment Part Start Signature
Dated: June 19, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E9-15152 Filed 6-25-09; 8:45 am]
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